[Ip-health] KEI Comments on NIH Proposed Exclusive License to Kite Pharma for Cancer Treatment

Claire Cassedy claire.cassedy at keionline.org
Thu Oct 20 11:15:18 PDT 2016


KEI Comments on NIH Proposed Exclusive License to Kite Pharma for Cancer

Submitted by Claire Cassedy  on 20. October 2016 - 13:53

Today, KEI submitted comments to the Notice published in the Federal
Register on October 5, 2016, entitled “Prospective Grant of Exclusive
Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the
Treatment of CD70 Expressing Cancers. [1]” KEI's comments addressed issues
with the NIH's processes for granting exclusive licenses, and transparency
in those licenses, resulting data, trials, pricing, and revenue.

Regarding the proposed license to Kite Pharma, KEI opposes the grant of an
exclusive license unless:

   1. The NIH conducts sufficient analysis and limits the terms and scope
of the license as required under 37 CFR 404.7 (a)(1)(ii­iii);
   2. The license contains sufficient safeguards regarding affordability
and reasonable pricing of the products, users and/or services developed
under the patent licenses;
   3. The license places restrictions on charging US residents higher
prices than the median prices charged in countries with the seven largest
GDP and per capita incomes of 50 percent or more than the United States per
capita income;
   4. In any case, and in addition to any other considerations of what
constitutes a reasonable price, the license holder is expected to limit the
cost of the products or services to U.S. residents to no more than the
lesser of either (a) the average annual per capita income in the United
States, or (b) the amount of the average annual per capita income in the
United States, per quality adjusted life year (QALY) benefit of the product.
   5. The exclusive rights will extend to five years from the first sale of
a product receiving approval by the U.S. FDA, or until the license holder
recovers at least $1 billion in cumulative global sales from the product,
whichever is shorter, and thereafter, the license will become
non-exclusive. After the first five years of exclusivity, the NIH can
extend the exclusivity by another 3 years, upon a showing that such
extension is reasonable in light of the risk adjusted R&D costs to bring
the product market, and the net revenues from sales.
   6. The license requires products and/or services are affordable in
developing countries, and explicitly allows the NIH to grant licenses to
the patents to the Medicines Patent Pool (MPP) for use in developing
countries? and
   7. The license requires transparent reporting on drug development costs,
royalties and revenues.

The full text of KEI's comments are available below.

[2] http://keionline.org/sites/default/files/KITE-NIH-20october2016.pdf

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